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HMPL-813 in Treating Patients With Glioblastoma

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ClinicalTrials.gov Identifier: NCT03231501
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Study Description
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Brief Summary:
This is an open-label study, to evaluated epitinib, which is a selective epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), to treat glioblastoma patients with EGFR gene amplification. As epitinib could cross blood-brain barrier (BBB), inhibition of EGFR may provide a novel mechanism in treating glioblastoma.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: epitinib succinate Phase 1

Detailed Description:
Epitinib could cross BBB and show its efficacy in brain metastasis tumors. Patients with histologically confirmed glioblastoma; standard treatment failed or no standard treatment as well as EGFR gene amplication are eligible. Patients will receive epitinib 120mg or 160mg epitinib daily. Epitinib is orally administered qd until patients reach intolerance or progression of disease. Tumor assessment takes place every 4 weeks. Simon two stage design was used, estimated making sample size of 35 cases.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a single arm, open label study with fixed dose.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib, Multi-center, Open-label Study of Epitinib Succinate (HMPL-813) in Treating Patients With Glioblastoma
Actual Study Start Date : January 26, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: single arm
This is a single arm study. It is an open-label study. The intervention is eptinib succinate.
 Drug: epitinib succinate
This is a single-arm open label study. A subject would take 160 mg of the study medication (epitinib succinate) every day on a 28-day cycle, until he or she reaches disease progression or intolerability.


Outcome Measures
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Primary Outcome Measures :
  1. objective response rate (ORR) [ Time Frame: 6 months ]
    the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed glioblastoma
  2. Standard treatment failed or no standard treatment
  3. EGFR gene amplification
  4. Clearly measurable lesions (according to Response Assessment in Neuro-Oncolog (RANO))
  5. Age ≥ 18
  6. Eastern Cooperative Oncology Group (ECOG) score ≤2

Exclusion Criteria:

  1. Use of Antiepileptic drugs were used] within 2 weeks before enrollment
  2. Immunotherapy, anti-angiogenesis or EGFR TKI and its downstream pathway signaling molecules and other targeted drugs within 4 weeks before enrollment; temozolomide chemotherapy, cranial radiotherapy or other systemic anti-tumor therapy within 3 weeks before enrollment
  3. Previous toxic effects of anticancer therapy have not yet been recovered (defined as not restored to 0 or 1 level, except alopecia) or have not been fully recovered from previous surgery
  4. Uncontrolled active infections such as acute pneumonia, Hepatitis B Virus (HBV) and so on
  5. Eye disease or dry eye syndrome history
  6. Positive pregnancy tested result
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231501


Contacts
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Contact: Rongjun Liu, M.D. 86-21-2067-3203 rongjunl@hmplglobal.com
Contact: Yan Wu, M.D. 86-21-2067-3000 ext 5830 yanwu@hmplglobal.com

Locations
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China, Shanghai
Huashan Hospital Recruiting
Shanghai, Shanghai, China, 200031
Contact: Xin Zhang, M.D.    +86-13761626836    xinzhanghs@126.com   
Contact: Wei Hua, M.D.    +86-15800589540    hs_glioma@126.com   
Principal Investigator: Ying MAO, PhD         
China, Zhejiang
The second hospital affiliated to Zhejiang University Medical School Recruiting
Hanzhou, Zhejiang, China, 310009
Contact: Jinfang Xu, M.D.    +86-13757118726    xjfxyz@126.com   
Contact: Chongran Sun, M.D.    +86-15925612402    sunchongran@126.com   
Principal Investigator: Jianmin Zhang, M.D.         
Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
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Study Chair: Rongjun Liu, M.D. Hutchison Medipharma Ltd.
More Information
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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT03231501    
Other Study ID Numbers: 2016-813-00CH3
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue